NCT06148545

Effect of Iron and Vitamin D Supplementation to Iron Status in Iron Deficiency Anemia

Efektifitas Pemberian Zat Besi Dan Vitamin D Terhadap Status Besi Pada Anak Dengan Anemia Defisiensi Besi

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Nadirah Rasyid Ridha · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Accepted

Summary

Iron and vitamin D are two essential micronutrients for the normal growth of young children, and their deficiencies are still a major health problem in developing countries, including Indonesia. A significant association between vitamin D deficiency and anemia has been reported throughout the world. Several studies in various populations all over the world suggest a high degree of association between Iron deficiency anemia and vitamin D deficiency. It is still controversial which deficiency causes the other but this association should be addressed in view of a better treatment proposal. The aim of the present study was to determine the effect of vitamin D supplementation on iron status in iron deficiency anemia.

Detailed description

This research is a randomized controlled trial study conducted in Makassar, South of Sulawesi, Indonesia from April to October 2023. This study was conducted on children with a diagnosis of iron deficiency anemia. Patients were divided into two groups, namely group A which received standard therapy (Fe preparations) 3 mg/kgBW/day, and group B (which received standard therapy combination vitamin D, 400IU). The inclusion criteria in this study were children aged 1-5 years, diagnosed with iron deficiency anemia, and parents/caregivers willing to include their children in this study. Children who had received iron preparation, and previous blood transfusion were excluded in this study. Patients who refused blood tests after giving therapy for 4 weeks were declared dropouts. Researchers will provide informed consent to parents/caregivers of children who met the research criteria. Anamnesis, general physical examination, and complete blood count (CBC) analysis were carried out: hemoglobin (Hb), Red Blood cell (RBC), Mean erythrocyte volume (MCV), Mean erythrocyte hemoglobin (MCH), Reticulocytes, serum iron, and serum ferritin. Iron deficiency anemia if the level of hemoglobin \<11 g/dL, microcytic Hypochromia, serum ferritin \< 30 pg/dl, then given iron and vitamin D preparation for 4 weeks, then checked again complete blood count, serum fe and serum ferritin. The research results are recorded in a research form and the data is grouped and SPSS version 21.0 software is used for data analysis. A P value \<0.05 was considered for statistical analysis. This study was approved by the ethics and research committee of the faculty of medicine, at Hasanuddin University

Conditions

• Iron Deficiency, Anaemia in Children

Interventions

Type	Name	Description
DRUG	Elemental iron	Group A who received standard therapy (Fe preparations) 3 mg/kg BW/day
DRUG	Elemental iron and Vit D	Group B received standard therapy (Fe preparations) 3 mg/kgBW/day combination with vitamin D, 400IU).

Timeline

• Start date: 2023-03-30
• Primary completion: 2023-09-29
• Completion: 2023-09-29
• First posted: 2023-11-28
• Last updated: 2023-11-28

Locations

1 site across 1 country: Indonesia